PNO-IV-97-036, on 970616,licensee Began Brachytherapy Procedure to Treat Patient for Cervical Cancer.Licensee Calculated That Patient May Have Received Max Dose of 400-500 Millirads to Skin
| ML20140J431 | |
| Person / Time | |
|---|---|
| Site: | 03002912 |
| Issue date: | 06/19/1997 |
| From: | Mark Shaffer, Spitzberg D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| References | |
| PNO-IV-97-036, PNO-IV-97-36, NUDOCS 9706190454 | |
| Download: ML20140J431 (2) | |
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June 19,1997 PRELIMINARY NOTIFICATION OF EVENT OR UNUSUAL OCCURRENCE PNO IV-97-036 This preliminary notification constitutes EARLY notice of events of POSSIBLE I safety or public interest significance. The information is as initially received without verification or evaluation, and is basically all that is known by Region IV staff in Arlington, Texas on this date.
Facility Licensee Emeraency Classification Hca Health Services Of Oklahoma Notification of Unusual Event Columbia Presbyterian Hospital Alert I 700 N.E.13th Street Site Area Emergency Oklahoma City, Oklahoma 73104 General Emergency Dockets: 03002912 License No: 35-12091-01 X Not Applicable 1
Subject:
BRACHYTHERAPY EVENT INVOLVING A RADIATION DOSE TO AN UNINTENDED TREATMENT SITE On June 18,1997, Region-IV received telephonic notification from the licensee of a medical event that occurred on June 18th at the licensee'.* facility in Oklahoma City, j Oklahoma. The licensee reported that at 4:30 p.m. on June 16,1997, the licensee began i
a brachytherapy procedure to treat a patient for cervical cancer. The procedure involved the placement of 5 cesium-137 sealed sources (4 sources containing a nominal 10 milligrams radium equivalent and 1 source containing a nominal 20 milligrams radium equivalent) in a tandeu/ ovoid applicator that had been placed in the desired treatment site, and secured with surgical packing material. A written directive was prepared by an authorized user physician which prescribed a total dose of 1,800 centigray (cGy) to be delivered over 46.45 hours5.208333e-4 days <br />0.0125 hours <br />7.440476e-5 weeks <br />1.71225e-5 months <br />. Between 3:00 and 6:45 a.m. on June 18,1997, the patient apparently pulled the applicator partially out. At 6:45 a.m. an attending medical resident checked on the patient, noted that the applicator had been partially removed and immediately notified the authorized user. At 8:00 a.m. a physician authorized user removed the applicator containing the sources and revised the written directive to reflect the removal. On the morning of June 19,1997, the authorized user re-inserted the applicator and brachytherapy sources, and intends to complete the treatment to obtain the original prescribed dose of 1,800 cGy.
Following completion of the procedure, the licensee expects that the patient will have received the intended dose to the desired treatment volume. However, it appears that intervention by the patient may have caused a brachytherapy radiation dose to an unintended treatment site, i
9706190454 970619
-I 7-036 PDR boll 9 )
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.A PNO-IV-97-036 .
the skin of the patient's inner thigh area. The licensee calculated that the patient may have received a maximum dose of 400-500 millirads to the skin. A visual examination of the effected area did not indicate reddening of the skin. The licensee does not expect any adverse health effect to the patient as a result of this medical event.
The licensee believes that patient intervention was the direct cause of the radiation dose to an unintended treatment site, and does not consider this medical event to be a misadministration as defined in 10 CFR 35.2. The licensee does not intend to notify the pt.tient that a misadministration occurred.
The state of Oklahoma has been informed.
l Region IV received notification of this occurrence by telephone from the licensee's I radiation safety officer at 3:00 p.m. (CDT) on June 18,1997. Region IV has informed NMSS.
Region IV intends to dispatch an inspector to review this event on June 24,1997. The l region also intends to request the assistance of a medical physician consultant to review this event.
This information has been discussed with the licensee and is current as of 10:00 a.m. on l June 19,1997.
Contact:
Mark R. Shaffer D. Blair Spitzberg l (817)860-8287 (8171860-8191 l
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